Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
详细描述
Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms.
- •Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- •A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
排除标准
- •Pregnancy, lactation or intended pregnancy.
- •Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
研究组 & 干预措施
Nicotine Gum 6
6 mg Nicotine medicated gum
干预措施: Nicotine Medicated Gum (Drug)
Nicotine Gum 4
4 mg Nicotine Gum
干预措施: 4 mg Nicotine Gum (Drug)
Nicotine Gum 2
2 mg Nicotine Gum
干预措施: 2 mg Nicotine Gum (Drug)
Nicotine Lozenge
4 mg Nicotine Lozenge
干预措施: 4 mg Nicotine Lozenge (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 12 hours post-dose
Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
Area Under the Curve (AUC)(0-t)
时间窗: 12 hours post-dose
AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL).
AUC (0-∞)
时间窗: 12 hours post-dose
AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
次要结局
- AUC(10 min)(10 minutes post-dose)